# K190161: Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride Mist, Ethyl Chloride Accustream 360* Medium Spray, Ethyl Chloride Accustream 360* Fine Spray

- Pathway: 510(k) (Traditional)
- Applicant: Gebauer Company
- Decided: May 7, 2019 after 97 days
- Product code: MLY (Vapocoolant Device)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K991514 (1999). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991514: Gebauer's Chloride Fine Nozze, Gebauer Co. (1999) Summary page 4.
- K032671: Gebauer's Skin Refrigerant (Mist Stream), Gebauer's Skin Refrigerant (Stream Spray), Models P/N 0386-0010-07, Gebauer Co. (2004) Summary page 5.

## Indications for use
Gebauer's Ethyl Chloride Topical Anesthetic Spray (Mist Spray, Fine Spray and Medium Spray): A vapocoolant (skin refrigerant) intended for topical application to control pain associated with injections (starting IV's and venipuncture), minor surgical procedures (such as lancing boils, or incision and drainage of small abscesses), and the temporary relief of minor sports injuries. The Fine and Medium Sprays are also intended for the treatment of myofascial pain caused by trigger points, restricted motion and muscle tension.

Source page: https://510kreport.com/device/K190161
Methodology: https://510kreport.com/methodology